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510(k) Data Aggregation

    K Number
    K254267

    Validate with FDA (Live)

    Device Name
    NanoPress 760A-BT (760A-BT)
    Manufacturer
    Mego Afek , Ltd.
    Date Cleared
    2026-02-24

    (56 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NanoPress™ 760A-BT pneumatic compression therapy system is indicated for:

    • Primary lymphedema
    • Secondary lymphedema
    • Venous insufficiency
    • Venous stasis ulcers
    • Dysfunction of the muscle pump
    Device Description

    Not Found

    AI/ML Overview

    N/A

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